Recall Z-0566-2018— Medtronic Sofamor Danek USA Inc

Class II · Terminated

Class II FDA medical device recall by Medtronic Sofamor Danek USA Inc, initiated 2017-12-22, terminated 2018-07-31. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only. Reason: Medtronic has discovered the product lot in question was noted as having a longer drill tip extension than what is indicated on the print specification..

Recalling firm
Medtronic Sofamor Danek USA Inc
Classification
Class II
Status
Terminated
Initiated
2017-12-22
Terminated
2018-07-31
Firm location
Memphis, TN, United States

Product description

Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only

Reason for recall

Medtronic has discovered the product lot in question was noted as having a longer drill tip extension than what is indicated on the print specification.

Data sourced from openFDA. This site is unofficial and independent of the FDA.